Heat Stress DisordersNCT06938932
Effects of Environmental Heat Exposure on Human Multiple Organ Function
A study testing High temperature exposure and Moderate temperature exposure in people with Heat Stress Disorders and Wounds and Injuries, run by Yinan Qu at 1 site in China.
Trial summary
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress Disorders, Wounds and Injuries, Body Temperature Changes
- What is being tested?
- High temperature exposure and Moderate temperature exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese nationality（aged 18-30 years healthy males and females）;
- With ability to read and understand Chinese smoothly;
- Living in Jinan during the study period;
- Body mass index ≥ 18.5 and ≤ 28;
- Normal resting ECG；
- Normal lung function: i. Forced vital capacity (FVC)≥80% of that predicted for gender, ethnicity, age and height; ii. Forced expiratory volume in one second (FEV1) ≥80% of that predicted for gender, ethnicity, age and height; iii. FEV1/FVC ratio≥80% of predicted values.
Who cannot join
- Medications or dietary supplements intake that may alter body temperature during the study period;
- Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with heat exposure will be a basis for exclusion;
- Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
- Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
- Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
- Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and depression;
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- Subjects with allergic diseases, such as allergic rhinitis and allergic asthma, etc;
- Subjects are pregnant, attempting to become pregnant or breastfeeding;
- Subjects who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than equal to a 5 pack year smoking history;
- Subjects living with a smoker who smokes inside the house;
- Subjects who are current drinking or have frequent alcohol use (defined as at least 1 time per week) in the past 6 months;
- Provisional exclusion criteria, such as acute infection in the past two weeks or taking antibiotics. (Subjects can be enrolled after 2 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exposure to Environmental Heat and Intervention Study
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
Read the detailed description
The objective of this study is to study changes in functions of multiple organs under heat exposure, which mainly include changes of cardiac function and lung function. In addition, biological samples such as blood samples, nasal fluid, and urine, etc were collected to explore changes in biomarkers such as complete blood count, liver function, kidney function, and inflammatory indicators, etc. Biochemical analysis and omics analysis were conducted to study the changes of human physiological function caused by heat exposure.
- Conditions
- Heat Stress Disorders, Wounds and Injuries, Body Temperature Changes, Multiple Organ Dysfunction
- Being tested
- High temperature exposure, Moderate temperature exposure
- Medical subject headings
- Heat Stress Disorders, Wounds and Injuries, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High temperature exposureOther
Subjects will be exposed to 35 degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods.
Moderate temperature exposureOther
Subjects will be exposed to 24degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods.
| Study group | Role | What they receive |
|---|---|---|
| High temperature group | Experimental | This group including 24 healthy subjects will be exposed to high temperature for about 3 hours in a chamber. Receives: Other: High temperature exposure |
| Moderate temperature group | Sham comparator | This group including 24 healthy subjects will be exposed to moderate temperature for about 3 hours in a chamber. Receives: Other: Moderate temperature exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Brachial arterial blood pressure will be measured
Measured: Systolic and diastolic blood pressure will be measured within 15 minutes before exposure and immediately after the exposure session, and every 15 minutes during exposure.
Cardiac output
Cardiac output will be measured by heart color ultrasound
Measured: Cardiac output will be checked within half an hour before exposure and immediately after exposure.
Heart rate variability
Heart rate variability will be measured using 24-hour holter electrocardiogram
Measured: Cardiac variability will be monitored in real time from half an hour before exposure to half an hour after exposure, with data automatically recorded every 8 seconds.
Change of forced expired volume in the first second (FEV1)
The changes of FEV1 will be measured by a smart spirometer. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion.
Measured: FEV1 will be checked within half an hour before exposure and 15 minutes after exposure.
Changes of forced vital capacity (FVC)
The changes of FVC will be measured by a smart spirometer.
Measured: FVC will be checked within half an hour before exposure and 15 minutes after exposure.
Changes of peak expiratory flow rate (PEF)
The changes of PEF will be measured by a smart spirometer.
Measured: PEF will be checked within half an hour before exposure and 15 minutes after exposure.
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
The changes of MEF25 will be measured by a smart spirometer.
Measured: MEF25 will be checked within half an hour before exposure and 15 minutes after exposure.
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
The changes of MEF50 will be measured by a smart spirometer.
Measured: MEF50 will be checked within half an hour before exposure and 15 minutes after exposure.
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
The changes of MEF75 will be measured by a smart spirometer.
Measured: MEF75 will be checked within half an hour before exposure and 15 minutes after exposure.
Inflammatory factors and antioxidant-related biomarkers in nasal cavity fluid
Inflammatory factors were detected by the ELASA
Measured: Collect nasal fluid samples half an hour before exposure and half an hour after exposure
Secondary outcomes (11)
Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure
The differential metabolic profiling in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics.
Measured: Prior to and 1 hour after exposure
Differences in transcriptome detected in blood between the two exposures and before and after each exposure
The differential transcriptome in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted transcriptomics.
Measured: Prior to and 1 hour after exposure
Differences in proteome detected in blood between the two exposures and before and after each exposure
The differentially expressed proteins in peripheral blood related to high temperature exposure will be detected by non-targeted proteomics
Measured: Prior to and 1 hour after exposure
EEG power in α band
EEG power in α band will be monitored by EEG measuring instrument
Measured: EEG power in α band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
EEG power in θ band
EEG power in θ band will be monitored by EEG measuring instrument
Measured: EEG power in θ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
EEG power in β band
EEG power in β band will be monitored by EEG measuring instrument
Measured: EEG power in β band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
EEG power in δ band
EEG power in δ band will be monitored by EEG measuring instrument
Measured: EEG power in δ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
Response event-related potentials (ERPs)
ERPs will be monitored by EEG measuring instrument, including P300, N1/P1 and so on.
Measured: ERPs will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
Frequency domain and energy ratio index, θ/β ratio
θ/β ratio will be monitored by EEG measuring instrument, which is an important parameter for response frequency domain and energy ratio index
Measured: θ/β ratio will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
Cerebral blood flow changes
Cerebral blood flow changes will be measured by transcranial doppler
Measured: Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure.
Differences in proteomics detected in nasal fluid between the two exposures and before and after each exposure
Collect nasal fluid samples for proteomics analysis
Measured: Prior to and 1 hour after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start21 May 2025
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat Stress DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yinan Qu
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Yinan Qu, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938932
- Sponsor's protocol ID
- LL20241102
- Status last verified
- May 2026
- First submitted
- 4 Apr 2025
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Environmental Heat and Intervention Study
- ClinicalTrials.gov ID
- NCT06938932
- Acronym / sponsor ID
- LL20241102
- Conditions
- Heat Stress Disorders, Wounds and Injuries, Body Temperature Changes, Multiple Organ Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yinan QuUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
Detailed description
The objective of this study is to study changes in functions of multiple organs under heat exposure, which mainly include changes of cardiac function and lung function. In addition, biological samples such as blood samples, nasal fluid, and urine, etc were collected to explore changes in biomarkers such as complete blood count, liver function, kidney function, and inflammatory indicators, etc. Biochemical analysis and omics analysis were conducted to study the changes of human physiological function caused by heat exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High temperature group | Experimental | Other: High temperature exposureThis group including 24 healthy subjects will be exposed to high temperature for about 3 hours in a chamber. |
| Moderate temperature group | Sham comparator | Other: Moderate temperature exposureThis group including 24 healthy subjects will be exposed to moderate temperature for about 3 hours in a chamber. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese nationality（aged 18-30 years healthy males and females）;
- With ability to read and understand Chinese smoothly;
- Living in Jinan during the study period;
- Body mass index ≥ 18.5 and ≤ 28;
- Normal resting ECG；
Key exclusion criteria (12 listed)
- Medications or dietary supplements intake that may alter body temperature during the study period;
- Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with heat exposure will be a basis for exclusion;
- Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
- Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
- Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High temperature exposureSubjects will be exposed to 35 degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods. | Other | High temperature group |
| Moderate temperature exposureSubjects will be exposed to 24degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods. | Other | Moderate temperature group |
Primary outcome
Systolic and diastolic blood pressure
Time frame: Systolic and diastolic blood pressure will be measured within 15 minutes before exposure and immediately after the exposure session, and every 15 minutes during exposure.
Brachial arterial blood pressure will be measured
Cardiac output
Time frame: Cardiac output will be checked within half an hour before exposure and immediately after exposure.
Cardiac output will be measured by heart color ultrasound
Heart rate variability
Time frame: Cardiac variability will be monitored in real time from half an hour before exposure to half an hour after exposure, with data automatically recorded every 8 seconds.
Heart rate variability will be measured using 24-hour holter electrocardiogram
Change of forced expired volume in the first second (FEV1)
Time frame: FEV1 will be checked within half an hour before exposure and 15 minutes after exposure.
The changes of FEV1 will be measured by a smart spirometer. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion.
Changes of forced vital capacity (FVC)
Time frame: FVC will be checked within half an hour before exposure and 15 minutes after exposure.
The changes of FVC will be measured by a smart spirometer.
Changes of peak expiratory flow rate (PEF)
Time frame: PEF will be checked within half an hour before exposure and 15 minutes after exposure.
The changes of PEF will be measured by a smart spirometer.
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
Time frame: MEF25 will be checked within half an hour before exposure and 15 minutes after exposure.
The changes of MEF25 will be measured by a smart spirometer.
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
Time frame: MEF50 will be checked within half an hour before exposure and 15 minutes after exposure.
The changes of MEF50 will be measured by a smart spirometer.
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
Time frame: MEF75 will be checked within half an hour before exposure and 15 minutes after exposure.
The changes of MEF75 will be measured by a smart spirometer.
Inflammatory factors and antioxidant-related biomarkers in nasal cavity fluid
Time frame: Collect nasal fluid samples half an hour before exposure and half an hour after exposure
Inflammatory factors were detected by the ELASA
11 secondary outcomes
Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure
Time frame: Prior to and 1 hour after exposure
Differences in transcriptome detected in blood between the two exposures and before and after each exposure
Time frame: Prior to and 1 hour after exposure
Differences in proteome detected in blood between the two exposures and before and after each exposure
Time frame: Prior to and 1 hour after exposure
EEG power in α band
Time frame: EEG power in α band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
EEG power in θ band
Time frame: EEG power in θ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
EEG power in β band
Time frame: EEG power in β band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
EEG power in δ band
Time frame: EEG power in δ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
Response event-related potentials (ERPs)
Time frame: ERPs will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
Frequency domain and energy ratio index, θ/β ratio
Time frame: θ/β ratio will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.
Cerebral blood flow changes
Time frame: Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure.
Differences in proteomics detected in nasal fluid between the two exposures and before and after each exposure
Time frame: Prior to and 1 hour after exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High temperature exposure and Moderate temperature exposure in people with Heat Stress Disorders and Wounds and Injuries, run by Yinan Qu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: Systolic and diastolic blood pressure will be measured within 15 minutes before exposure and immediately after the exposure session, and every 15 minutes during exposure.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.